The purpose of this study is to investigate the impacts of home-based couple HIV-testing and counseling and male partner education on partner HIV testing and other critical maternal and infant health outcomes during pregnancy and the postpartum period. Additionally, the study seeks to assess the cost-effectiveness of this approach.

Involvement of men during the antenatal and postpartum period, including HIV testing of male partners, can have substantial benefits for women and infants. In observational studies, male participation in antenatal care has been associated with increased uptake of prevention of mother-to-child transmission (PMTCT) interventions, and more recently, a study in Kenya found a significant HIV-free survival benefit for children of HIV-infected women whose male partners attended antenatal care where couple HIV testing was offered. In this study only 31% of ~450 men invited for counseling and testing came to clinic, highlighting the challenges faced across sub-Saharan Africa when trying to access male partners of pregnant women.

In areas of high HIV-1 prevalence, high levels of male involvement may be readily achievable because home-based counseling and testing is highly acceptable and the benefits of male participation and HIV testing extend to HIV-uninfected pregnant and postpartum women and infants. Reaching out to men during pregnancy may reduce incident HIV infection and vertical transmission among these women, but efforts to engage men in antenatal care in Western Kenya have thus far achieved limited success. This intervention may achieve gains beyond prevention of maternal and infant HIV-1 acquisition through identification of HIV-infected men who would otherwise not learn their status or delay treatment, and by improving child health through targeted education of male partners. When administered in a home-based setting simple, established interventions such as the promotion of exclusive breastfeeding have been shown to be associated with significant reductions in child mortality. Home-based approaches also lend themselves to integration with targeted interventions such as promotion of HIV testing among male partners of at-risk pregnant women. Furthermore, a successful HIV testing program for male partners of pregnant women has potential to reach a large number of men who may be unaware of their HIV status or who are HIV-infected but not in care, providing linkages to treatment clinics and promoting prevention interventions, such as safe sex and voluntary male circumcision for those who are uninfected.

In this randomized clinical trial up to 600 couples (300 in each treatment arm) will be randomized to standard antenatal care or home-based partner education and HIV testing (HOPE) as part of routine pregnancy services. Women will be enrolled at the antenatal clinic in Kisumu District Hospital, Kisumu, Kenya. Couples in the control group will receive the HOPE Intervention, featuring home-based couple counseling and HIV testing as well as key educational messages concerning HIV prevention behaviors, facility delivery, exclusive breastfeeding, and post-partum family planning. Women in the control arm will be invited to bring their male partners to the antenatal clinic for voluntary clinic testing and counseling. Women will be followed up at clinic visits 6-weeks and 14-weeks postpartum and again with their male partner 6-months post-partum. These follow-up visits will include questionnaires to measure uptake of HIV testing, facility delivery, exclusive breastfeeding and postpartum contraceptive use as well as linkage to HIV care. Cost-effectiveness of the intervention will also be evaluated in order to inform future scale-up.

First, the investigators hypothesize that successful implementation of HOPE will result in higher uptake of male partner HIV testing, couple testing and disclosure of HIV status. The investigators also hypothesize that there will be benefits to HIV-infected and HIV-uninfected women and their children who will have improved uptake of interventions to improve maternal and child health. Specifically, the investigators anticipate higher levels of facility delivery, optimal breastfeeding practices, and post-partum contraceptive use, as well as increased uptake of antiretroviral treatment for HIV+ women in the intervention arm, relative to the control arm. Second, the investigators hypothesize that greater than 85% of HIV-1-infected men identified through home-based partner education and testing (HOPE) will access care and treatment services, and, overall, more women in the HOPE arm will know their partners' status at each time point and more partners will be in care and treatment. Third, the investigators predict that uptake of counseling and testing and HIV prevalence among male partners and family members will be high enough to make this approach cost-effective from both payer and societal perspectives.

At each follow-up visit, women will be asked whether they have resumed receptive sexual intercourse and, if so, the general time frame that they resumed sex. Upon reporting that they have resumed sexual activity they will no longer be asked this question at remaining interviews.

Female participants will be asked to assess their partner's level of condom use during sexual intercourse in the previous 6 months (at enrollment and 6 months postpartum) and/or since the last study interview. Options include 1) always, 2) most occasions, 3) rarely, and 4) never.

After reporting having resumed sexual activity, women will be asked whether they are using contraception. If so, they will be asked what type of contraceptive they have used and how often (for oral medication) or when (for an injectable) they last utilized the contraceptive.

Subjects randomized to the intervention arm will be asked to identify their partner's HIV status during enrollment and at 6 months postpartum. The difference between awareness of partner HIV status before and after the intervention will be evaluated.

Pregnant women and their male partners will receive home-based couple HIV testing and counseling and partner education 1-2 weeks after enrollment. The intervention will include educational messages concerning socio-behavioral, condom-based, and treatment-oriented approaches to prevention of horizontal and vertical HIV transmission, based on the status of each of the partners. The couple will also be educated about the importance of facility delivery, exclusive breastfeeding, family planning, and post-partum contraception.

During the HOPE Intervention, the purpose and design of the study will be explained to male partners. Men will be asked to provide written informed consent for study participation. Provided they consent, men will complete a questionnaire asking for sociodemographic characteristics, medical and sexual history, behavioral data and information on prior HIV testing and counseling.

Behavioral: HOPE Intervention

If the male partner chooses not to complete the study questionnaire, he may decline and participate only in the HOPE intervention component of the study. (This does not preclude the possibility of the female partner continuing to participate in the study.) Investigators anticipate that this will occur and also expect that some women and male partners randomized to the intervention arm will refuse the HOPE intervention when offered. Study staff will attempt to collect data on reasons for refusal to participate and will continue to follow these couples through 6 months postpartum to collect maternal and infant outcome data, provided the female partner does not withdraw from the study.

Key educational messages will be presented using an electronic tablet highlighting key messages and will include with relevant images as visual aids. This will help to facilitate comprehension and ensure that all relevant materials are covered during each intervention session.

Experimental: INVITE Intervention

Pregnant women will be tested and encouraged to bring their male partners to the antenatal clinic for testing. Women will receive a clinic invitation to give to their male partners to attend the next visit for couple HIV counseling and testing. The couples will also be offered the relevant components of the intervention at the final study visit, 6 months postpartum.

Behavioral: INVITE Intervention

Women will receive a clinic invitation to give to their male partners to attend the next antenatal visit for couple HIV counseling and testing.

≥ 14 years old (all pregnant females 14-17 years old are emancipated minors per Kenyan law)

Current stable partnership (married or cohabiting)

Planning on living in vicinity (approx. 40 km or less from clinic) for 9 months postpartum

Willing to be randomized to intervention or standard of care

Willing to participate in couple HIV testing and counseling

No recent history of intimate partner violence (within last month with their current partner)

Male partner not present during screening visit

Males:

≥ 18 years old

Willing to participate in couple HIV testing and counseling

Exclusion Criteria:

Females:

≤ 8 weeks gestation

< 14 years old (all pregnant females 14-17 years old are emancipated minors per Kenyan law)

Not in a current stable partnership (not married or not cohabiting)

Not planning on living in vicinity (approx. 40 km or less from clinic) for 9 months postpartum

Recent history of intimate partner violence (within last month with their current partner)

Unwilling to be randomized to intervention or standard of care

Unwilling to participate in couple HIV testing and counseling

Male partner present during screening visit

Males:

< 18 years old

Unwilling to participate in couple HIV testing and counseling

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784783

Locations

Kenya

Kisumu District Hospital

Kisumu, Nyanza, Kenya, 40100

Sponsors and Collaborators

University of Washington

National Institutes of Health (NIH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)